BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 14644784 · Received June 9, 2022

    Report

    Report Number
    1219930-2022-02155
    Event Type
    Death
    Date Received
    June 9, 2022
    Date of Event
    August 9, 2021
    Report Date
    September 22, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: TOTALLY LAPAROSCOPIC PANCREATICODUODENECTOMY: COMPARISON BETWEEN EARLY AND LATE PHASE OF AN INITIAL SINGLE-CENTER LEARNING CURVE SOURCE: INDIAN JOURNAL OF SURGICAL ONCOLOGY 12(4) DOI:10.1007/S13193-021-01422-5. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE OUTCOMES OF PATIENTS WHO UNDERWENT LAPAROSCOPIC PANCREATICODUODENECTOMY (LPD) IN THE EARLY PHASES FOLLOWING IMPLEMENTATION OF LPD VS. THOSE WHO UNDERWENT LPD IN THE LATER PHASE OF THE STUDY, WHICH WAS CONDUCTED BETWEEN JANUARY 2017 AND MARCH 2020. IT WAS NOTED THAT THE GASTRIC ANTRUM WAS RESECTED WITH A 60-MM STAPLER WITH PURPLE CARTRIDGE USING A POWER HANDLE, THE FIRST JEJUNAL LOOP WAS SECTIONED WITH A 60-MM TRISTAPLE RELOAD WITH POWER HANDLE, AND A SIDE-TO-SIDE GASTROJEJUNOSTOMY WAS PERFORMED USING A 60-MM LINEAR STAPLER WITH A PURPLE CARTRIDGE WITH POWER STAPLER AND A SUTURE. THERE WERE 52 PATIENTS INCLUDED IN THE STUDY AND COMPLICATIONS INCLUDED: POST-OPERATIVE PANCREATIC FISTULA (POPF) TREATED ENDOSCOPICALLY, PERCUTANEOUSLY AND BY REOPERATION WITH RESECTION OF THE PANCREATIC STUMP, POST-PANCREATECTOMY HEMORRHAGE (PPH) TREATED WITH PERCUTANEOUS EMBOLIZATION AND RE-OPERATION LEADING TO ICU ADMISSION, DELAYED GASTRIC EMPTYING (DGE), AND INTRA-ABDOMINAL COLLECTION AND BILIARY LEAKAGE, ALSO TREATED WITH RE-OPERATION. IN ADDITION, TWO PATIENTS WITH PPH DECEASED WITHIN 90 DAYS FOLLOWING SURGERY.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE OUTCOMES OF PATIENTS WHO UNDERWENT LAPAROSCOPIC PANCREATICODUODENECTOMY (LPD) IN THE EARLY PHASES FOLLOWING IMPLEMENTATION OF LPD VS.THOSE WHO UNDERWENT LPD IN THE LATER PHASE OF THE STUDY, WHICH WAS CONDUCTED BETWEEN JANUARY 2017 AND MARCH 2020. IT WAS NOTED THAT THE GASTRIC ANTRUM WAS RESECTED WITH A 60-MM STAPLER WITH PURPLE CARTRIDGE USING A POWER HANDLE, THE FIRST JEJUNAL LOOP WAS SECTIONED WITH A 60-MM TRISTAPLE RELOAD WITH POWER HANDLE, AND A SIDE-TO-SIDE GASTROJEJUNOSTOMY WAS PERFORMED USING A 60-MM LINEAR STAPLER WITH A PURPLE CARTRIDGE WITH POWER STAPLER AND A SUTURE. THERE WERE 52 PATIENTS INCLUDED IN THE STUDY AND COMPLICATIONS INCLUDED: TWO PATIENTS WERE DECEASED FROM POST-PANCREATECTOMY HEMORRHAGE (PPH) WITHIN 90 DAYS FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631210 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Death| L| H| O SEE H10